AnxietyNCT01577290
An Internet-administered, Mindfulness Training Program for the Treatment of Anxiety
A study testing Internet-administered Mindfulness Training Program and Discussion group in people with Anxiety and Depression, run by Umeå University at 1 site in Sweden.
Trial summary
The purpose of this study is to examine the effects of a 10 week mindfulness training program -- without therapist-support -- as treatment of anxiety. Effects on depression, quality of life, and insomnia symptoms will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depression, Insomnia
- What is being tested?
- Internet-administered Mindfulness Training Program and Discussion group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2012to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Satisfy DSM-IV criteria for an anxiety disorder
- Living in Sweden and being able to read Swedish
- Access to computer with internet connection
Who cannot join
- Currently receiving other psychological treatment
- Non-stable use of psychoactive medication
- Deemed suicidal
- Deemed to suffer from other psychological disorder, e.g. psychosis, bipolarity etc.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Psychology, Umeå University
Umeå, Västerbotten County, 90181
About this study
The purpose of this study is to examine the effects of a 10 week mindfulness training program -- without therapist-support -- as treatment of anxiety. Effects on depression, quality of life, and insomnia symptoms will also be studied.
Read the detailed description
Previous research has provided evidence for the thesis that training in mindfulness can decrease symptoms of anxiety and depression. This study will examine the effects of a 10 week mindfulness training program -- without therapist-support -- as treatment of anxiety. Effects on depression, quality of life, and insomnia symptoms will also be studied.
- Conditions
- Anxiety, Depression, Insomnia
- Being tested
- Internet-administered Mindfulness Training Program, Discussion group
- Keywords
- Anxiety, Depression, Insomnia, Mindfulness, Internet
- Medical subject headings
- Anxiety Disorders, Depression, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-administered Mindfulness Training ProgramBehavioural
A 10 week, internet-administered mindfulness training program, featuring no therapist-support. 10 minutes of training, twice per day.
Discussion groupBehavioural
Access to a discussion group with the possibility of sharing experiences, methods of relief, and the like.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness training | Experimental | Group receives mindfulness training. Receives: Behavioral: Internet-administered Mindfulness Training Program |
| Discussion group | Active comparator | Group has access to a discussion group. Receives: Behavioral: Discussion group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Beck Anxiety Inventory (BAI)
21 item rating scale for anxiety symptoms.
Measured: 24 hours
Change from baseline in Beck Anxiety Inventory (BAI)
21 item rating scale for anxiety symptoms.
Measured: 6 months
Secondary outcomes (6)
Change from baseline in Beck Depression Inventory (BDI)
21 item rating scale for depression symptoms.
Measured: 24 hours
Change from baseline in Beck Depression Inventory (BDI)
21 item rating scale for depression symptoms.
Measured: 6 months
Change from baseline in Quality Of Life Inventory (QOLI)
The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health.
Measured: 24 hours
Change from baseline in Quality Of Life Inventory (QOLI)
The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health.
Measured: 6 months
Change from baseline in Insomnia Severity Index (ISI)
7 item rating scale of insomnia symptoms.
Measured: 24 hours
Change from baseline in Insomnia Severity Index (ISI)
7 item rating scale of insomnia symptoms.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Carlbring, PhD, Umeå University
- Investigators
- Per Carlbring, Professor, Principal investigator, Department of Psychology, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577290
- Sponsor's protocol ID
- IMA
- Status last verified
- Oct 2016
- First submitted
- 11 Apr 2012
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Boettcher J, Astrom V, Pahlsson D, Schenstrom O, Andersson G, Carlbring P. Internet-based mindfulness treatment for anxiety disorders: a randomized controlled trial. Behav Ther. 2014 Mar;45(2):241-53. doi: 10.1016/j.beth.2013.11.003. Epub 2013 Nov 25.
PubMed 24491199
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Internet-administered, Mindfulness Training Program for the Treatment of Anxiety
- ClinicalTrials.gov ID
- NCT01577290
- Acronym / sponsor ID
- IMA
- Conditions
- Anxiety, Depression, Insomnia
- Keywords
- Anxiety, Depression, Insomnia, Mindfulness, Internet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 13 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effects of a 10 week mindfulness training program -- without therapist-support -- as treatment of anxiety. Effects on depression, quality of life, and insomnia symptoms will also be studied.
Detailed description
Previous research has provided evidence for the thesis that training in mindfulness can decrease symptoms of anxiety and depression. This study will examine the effects of a 10 week mindfulness training program -- without therapist-support -- as treatment of anxiety. Effects on depression, quality of life, and insomnia symptoms will also be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness training | Experimental | Behavioral: Internet-administered Mindfulness Training ProgramGroup receives mindfulness training. |
| Discussion group | Active comparator | Behavioral: Discussion groupGroup has access to a discussion group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Satisfy DSM-IV criteria for an anxiety disorder
- Living in Sweden and being able to read Swedish
- Access to computer with internet connection
Key exclusion criteria (4 listed)
- Currently receiving other psychological treatment
- Non-stable use of psychoactive medication
- Deemed suicidal
- Deemed to suffer from other psychological disorder, e.g. psychosis, bipolarity etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-administered Mindfulness Training ProgramA 10 week, internet-administered mindfulness training program, featuring no therapist-support. 10 minutes of training, twice per day. | Behavioural | Mindfulness training |
| Discussion groupAccess to a discussion group with the possibility of sharing experiences, methods of relief, and the like. | Behavioural | Discussion group |
Primary outcome
Change from baseline in Beck Anxiety Inventory (BAI)
Time frame: 24 hours
21 item rating scale for anxiety symptoms.
Change from baseline in Beck Anxiety Inventory (BAI)
Time frame: 6 months
21 item rating scale for anxiety symptoms.
6 secondary outcomes
Change from baseline in Beck Depression Inventory (BDI)
Time frame: 24 hours
Change from baseline in Beck Depression Inventory (BDI)
Time frame: 6 months
Change from baseline in Quality Of Life Inventory (QOLI)
Time frame: 24 hours
Change from baseline in Quality Of Life Inventory (QOLI)
Time frame: 6 months
Change from baseline in Insomnia Severity Index (ISI)
Time frame: 24 hours
Change from baseline in Insomnia Severity Index (ISI)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Results publication: PubMed 24491199Boettcher J, Astrom V, Pahlsson D, Schenstrom O, Andersson G, Carlbring P. Internet-based mindfulness treatment for anxiety disorders: a randomized controlled trial. Behav Ther. 2014 Mar;45(2):241-53. doi: 10.1016/j.beth.2013.11.003. Epub 2013 Nov 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Carlbring, Professor principal investigator
Department of Psychology, Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-administered Mindfulness Training Program and Discussion group in people with Anxiety and Depression, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Beck Anxiety Inventory (BAI) (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01577290, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.